FDA approves first new tobacco products under 'substantial equivalence' rules

By Alaric DeArment

SILVER SPRING, Md. — The Food and Drug Administration is allowing the marketing of two new cigarette brands under regulations that allow tobacco companies to market new products if they can prove they are similar enough to products already on the market.

The FDA announced Tuesday that it had authorized Newport Non-Menthol Gold Box and Newport Non-Menthol Gold Box 100s, made by Lorillard Tobacco Co., calling them the first products authorized under "substantial equivalence" rules since the Family Smoking Prevention and Tobacco Control Act of 2009 gave the FDA the power to regulate tobacco products. Four other products were denied marketing authorization.

"Today's historic announcement marks an important step toward the FDA's goal of reducing preventable disease and death caused by tobacco," FDA commissioner Margaret Hamburg said. "The FDA has unprecedented responsibility to protect public health by not allowing new tobacco products under FDA's authority to come to market without FDA review."

Under the rules, a new tobacco product can be approved if it has different characteristics from a preexisting product, as long as it does not raise new public health issues. Any product that does raise different questions of public health will be declared not substantially equivalent, and thus not approved. The FDA said its decision not to approve the other four products was because of lack of information about their design and lack of evidence showing that adding new ingredients didn't raise different questions about public health.